XIENCE Sierra™ 1550225-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08717648227011), received between Jun 15, 2018 and Dec 9, 2021 — classified as 1 death, 14 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Tachycardia

  MAUDE report 12969032 ↗
• MalfunctionSep 15, 2021Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 2.25X15MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS TO THE TARGET LESION. WHEN PULLING THE SDS BACK INTO THE GUIDE EXTENSION CATHETER, RESISTANCE WAS FELT. THE SDS INTERACTED WITH THE GUIDE CATHETER AND THE STENT STRUT FLARED. THE SDS AND GUIDE EXTENSION CATHETER HAD TO BE REMOVED AS A SINGLE UNIT. A NON-ABBOTT SDS WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUES. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12478348 ↗
• MalfunctionApr 29, 2021Material Rupture; Activation Failure; Material Rupture; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 2.25X15MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE; HOWEVER, THE BALLOON FAILED TO INFLATE WITH THE INDEFLATOR. INFLATION WAS ATTEMPTED THREE TIMES AND WOULD NOT HOLD PRESSURE. THE SDS WAS REMOVED AND ON THE TABLE, AN ATTEMPT WAS MADE TO INFLATE THE BALLOON AND A BALLOON LEAK WAS OBSERVED. ANOTHER SAME SIZE XIENCE SIERRA AND THE SAME INDEFLATOR WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11749846 ↗
• InjuryMar 3, 2021Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY ARTERY (RCA). A 3.5X33MM XIENCE SIERRA WAS FIRST DEPLOYED SUCCESSFULLY WITH NO ISSUES IN THE PROXIMAL RCA. A SECOND 2.25X15MM XIENCE SIERRA WAS ATTEMPTED TO BE DELIVERED THROUGH THE FIRST DEPLOYED STENT; HOWEVER, RESISTANCE WAS MET WITH STENT. DURING REMOVAL OF THE SECOND XIENCE SIERRA THE STENT DISLODGED. CASE LASTED FROM 5 P.M. TO 1 A.M. AND PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL AS THE DOCTOR COULDN'T CROSS ANOTHER STENT TO CRUSH THE SECOND XIENCE STENT. ONCE AT THE OTHER HOSPITAL THE DISLODGED STENT WAS CRUSHED INTO THE VESSEL WALL. PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11405095 ↗
• InjuryOct 15, 2020Entrapment of Device; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Entrapment of Device; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DISTAL LEFT ANTERIOR DESCENDING ARTERY. DURING ADVANCEMENT OF THE 2.25X15MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS), THE STENT BECAME CAUGHT WITH A PROJECTING STRUT OF A PREVIOUSLY IMPLANTED UNSPECIFIED STENT. THE SDS WAS PUSHED BUT IT FAILED TO CROSS. STRONG RESISTANCE WAS FELT DURING REMOVAL. FORCE WAS APPLIED AND THE STENT DISLODGED. THE DISLODGED XIENCE SIERRA STENT WAS RETRIEVED WITH A SNARE DEVICE. NO OTHER STENT WAS IMPLANTED. THE PROCEDURE WAS COMPLETED USING A BALLOON DILATATION CATHETER. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10684391 ↗
• InjurySep 17, 2020Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CONCENTRIC, HEAVILY CALCIFIED, HEAVILY TORTUOUS, 90% STENOSED, DE NOVO PROXIMAL LEFT CIRCUMFLEX (PLCX). AFTER LESION PRE-DILATATION, A 2.25X15MM XIENCE SIERRA DRUG ELUTING STENT (DES) WAS ADVANCED BUT DUE TO THE ANATOMY, BECAME STUCK WITH A THE PREVIOUSLY IMPLANTED STENT IN THE CIRCUMFLEX AND DISLODGED. A SNARE WAS ATTEMPTED TO GRAB IT AND PULL IT OUT BUT FAILED. A NON-ABBOTT DEVICE WAS USED TO PUSH THE DISLODGED SIERRA STENT AGAINST THE PREVIOUSLY IMPLANTED STENT AND ANOTHER SIERRA STENT WAS ADVANCED AND IMPLANTED TO EMBED THE DISLODGED STENT INTO THE PREVIOUSLY IMPLANTED STENT. POST- DILATATION WAS PERFORMED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE LESION WAS AGAIN PRE-DILATED AND A NON-ABBOTT STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 10550402 ↗
• MalfunctionMar 12, 2020Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN AN UNKNOWN VESSEL. A 2.25X15NN RX XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS INSERTED AND ADVANCED TO THE TARGET LESION HOWEVER THE DEVICE DID NOT HOLD PRESSURE WHEN INFLATION WAS ATTEMPTED. THE SDS WAS REMOVED WITHOUT ISSUES AND REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9824704 ↗
• InjuryDec 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT PRESENTED WITH NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) THEREFORE TWO (2.25X15MM AND 3.50X28MM) XIENCE SIERRA STENTS WERE IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH A SHORTNESS OF BREATH. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea

  MAUDE report 9441207 ↗
• InjuryDec 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT PRESENTED WITH NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) THEREFORE THE 2.25X15MM XIENCE SIERRA WAS IMPLANTED. ON (B)(6) 2019 THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN. IT IS UNKNOWN WHAT TREATMENT WAS PERFORMED AND THE FINAL PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 9438228 ↗
• InjuryNov 19, 2019Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED, LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). TWO UNSPECIFIED SIERRA STENTS WERE IMPLANTED IN THE PROXIMAL TO MID LAD, WITHOUT ISSUES. THERE WAS RESIDUAL STENOSIS DISTALLY, THEREFORE A 2.25 X 15MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED. THE 2.25 X 15 MM SDS CROSSED THROUGH ONE IMPLANTED SIERRA STENT BUT DID NOT FULLY CROSS THROUGH THE OTHER IMPLANTED SIERRA STENT. THE LESION WAS FURTHER DILATED WITH A 2.0 BALLOON, AND AN ATTEMPT WAS MADE TO DELIVER THE SDS AGAIN, WITH NO SUCCESS. RESISTANCE WAS MET WITH THE GUIDE CATHETER DURING REMOVAL AND THE SDS DID NOT RETRACT INTO THE GUIDE CATHETER. IT IS SUSPECTED THE STENT BECAME DAMAGED. THE DEVICES WERE REMOVED TOGETHER AS A SINGLE UNIT. FOLLOWING REMOVAL, IT WAS OBSERVED THAT STENT WAS NO LONGER ON THE SDS AND HAD DISLODGED IN THE PATIENT. THE STENT WAS CAUGHT INSIDE THE IMPLANTED SIERRA STENT. ATTEMPTS TO RETRIEVE, DEPLOY, OR CRUSH THE STENT WERE UNSUCCESSFUL. THE PATIENT WAS SENT TO SURGERY AND A CORONARY ARTERY BYPASS GRAFT (CABG) WAS PERFORMED. THE STENT WAS NOT FOUND DURING THE CABG. THE PATIENT DEVELOPED ACUTE R

  Patient problems: Foreign Body In Patient; Respiratory Failure

  MAUDE report 9343881 ↗
• MalfunctionNov 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO PREPARATION OF THE 2.25X15MM RX XIENCE SIERRA STENT DELIVERY SYSTEM, THE STENT IMPLANT DISLODGED IN THE YELLOW PROTECTIVE SHEATH DURING REMOVAL OF THE SHEATH. THERE WAS NO PATIENT INVOLVEMENT. A NEW XIENCE SIERRA WAS USED TO SUCCESSFULLY CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9323024 ↗
• InjurySep 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CORONARY PROCEDURE, A 2.5 X 33 MM XIENCE SIERRA STENT AND A 2.25 X 15 MM XIENCE SIERRA STENT WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. POST DILATATION WAS PERFORMED AT THE 2.25 X 15 MM XIENCE SIERRA STENT AND A PERFORATION OCCURRED. THE 2.8 X 19 MM GRAFTMASTER STENT WAS ADVANCED; HOWEVER, THE GRAFTMASTER WAS UNABLE TO CROSS THROUGH THE 2.25 X 15 MM XIENCE SIERRA STENT. SEVERAL ATTEMPTS WERE MADE; HOWEVER, THE GRAFTMASTER WAS UNABLE TO CROSS. THE DEVICE WAS REMOVED, AND IT WAS NOTED THAT THE DELIVERY SYSTEM SHAFT WAS KINKED. ADDITIONAL BALLOON DILATATION WAS PERFORMED TO TREAT THE PERFORATION, AND THE PERFORATION WAS SEALED. POST PROCEDURE, THE PATIENT WAS IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 9131829 ↗
• InjurySep 14, 2019Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TORTUOUS AND CALCIFIED LESION OF THE FIRST DIAGONAL CORONARY ARTERY. POST THE DEPLOYMENT OF A 2.25 X 18 MM XIENCE SIERRA STENT, A DISTAL EDGE DISSECTION WAS NOTED. A 2.25 X 08 XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED THROUGH THE DEPLOYED STENT TO TREAT THE DISSECTION; HOWEVER, RESISTANCE WAS MET AND THE 2.25 X 08 XIENCE SIERRA STENT DISLODGED FROM THE SDS AT THE PROXIMAL PART OF THE DEPLOYED STENT. NEGATIVE PRESSURE HAD BEEN APPLIED TO THE SDS. THE GUIDE WIRE WAS INADVERTENTLY PULLED OUT OF THE DIAGONAL AND ON RE-WIRING THE LESION, THE WIRE PASSED BEHIND THE DISLODGED STENT STRUTS NOT THROUGH THE STENT. THE STENT WAS THEREFORE CRUSHED INTO THE PROXIMAL SEGMENT OF THE STENTED VESSEL WITH AN UNSPECIFIED BALLOON CATHETER. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 9056967 ↗
• MalfunctionAug 30, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A RESTENOSED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.25 X 15 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THE STENT WAS DEPLOYED WITHOUT ISSUES. DURING REMOVAL OF THE SDS, RESISTANCE WITH THE ANATOMY WAS FELT. THE SDS WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8952680 ↗
• DeathApr 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, A 2.25X15MM XIENCE SIERRA STENT WAS SUCCESSFULLY IMPLANTED IN THE PROXIMAL CIRCUMFLEX (CX) CORONARY ARTERY, 90% STENOSED LESION. PER IMAGING, THE STENT WAS WELL APPOSED WITHOUT ANY DISSECTION OBSERVED. ON (B)(6) 2019, THE PATIENT WAS FOUND UNRESPONSIVE ON THE BATHROOM FLOOR, EXPIRED DUE TO SUDDEN CARDIAC ARREST. AUTOPSY WAS NOT PERFORMED. PER PHYSICIAN, THE PATIENT HAD SEVERE MITRAL REGURGITATION AND WAS BEING EVALUATED FOR THERAPY PRIOR TO HER DEATH. STENT THROMBOSIS WAS POSSIBLE, ALTHOUGH PER PHYSICIAN, UNLIKELY AS THE PATIENT WAS ON ANTICOAGULANTS. THERE WAS NO DEVICE MALFUNCTION REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Thrombosis

  MAUDE report 8524179 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI) ON (B)(6) 2019 AND A 2.25 X 15 MM XIENCE ALPINE STENT WAS IMPLANTED WITHOUT REPORTED ISSUE. ON (B)(6) 2019 THE PATIENT WAS READMITTED AND HOSPITALIZED FOR ANGINA. THERE WAS NO REPORTED TREATMENT; THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 8375129 ↗
• InjuryDec 20, 2018Entrapment of Device; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Entrapment of Device; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS RIGHT CORONARY ARTERY. A 3.25 X 28 MM XIENCE SIERRA STENT WAS IMPLANTED ALONG WITH 3 OTHER UNSPECIFIED XIENCE SIERRA STENTS WITHOUT ANY DEVICE ISSUES. AS A GAP WAS NOTED BETWEEN 2 STENTS, A 2.25 X 15 MM XIENCE SIERRA STENT WAS ADVANCED TO THE LESION; HOWEVER, THE STENT BECAME CAUGHT WITH THE 3.25 X 28 MM SIERRA STENT. IT WAS NOTED UNDER ANGIOGRAPHY THAT THE 3.25 X 28 MM SIERRA STENT WAS NOT DAMAGED. THE 2.25 X 15 MM SIERRA STENT DELIVERY SYSTEM (SDS) WAS THEN MOVED BACK AND FORTH TO REMOVE THE STENT, AND IT DISLODGED. THEREFORE, AN UNSPECIFIED TREK AND A 1.5 X 12 MM MINI TREK BALLOON CATHETER WERE USED TO CRUSH THE STENT TO THE 3.25 X 28 MM STENT. POST-DILATATION WAS THEN PERFORMED WITH A 3.5 X 15 MM NC TREK BALLOON CATHETER TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 8184228 ↗
• MalfunctionNov 16, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY THAT WAS HEAVILY CALCIFIED. AFTER ROTABLATION WAS PERFORMED, BALLOONS WERE USED FOR PREDILATATION. THE 3.0 X 33 MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION WITHOUT RESISTANCE, HOWEVER, DURING THE FIRST INFLATION, THE STENT EXPANDED BUT CONTRAST WAS LEAKING AND IT WAS NOT POSSIBLE TO INFLATE THE BALLOON. THE XIENCE SIERRA WAS REMOVED FROM THE ANATOMY AND AN ATTEMPT WAS MADE TO INFLATE THE BALLOON. THE BALLOON EXPANDED; HOWEVER, THERE WERE MULTIPLE HOLES IN THE BALLOON. THEN, THE 2.25 X 15 MM XIENCE SIERRA WAS ADVANCED TO THE LESION BUT RUPTURED BELOW RATED BURST PRESSURE DURING THE FIRST INFLATION. BOTH SDS BALLOONS RUPTURED PREMATURELY POST-ROTABLATION. A 3 X 32 MM NON-ABBOTT STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE AND AIR ASPIRATION WAS PERFORMED OUTSIDE THE ANATOMY PRIOR TO USE WITHOUT ANY ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8079906 ↗
• InjuryOct 10, 2018Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HEAVY CALCIFICATION. THE PATIENT WAS TREATED WITH A 2.5X18 MM XIENCE SIERRA. THE PATIENT EXPERIENCED NO UNTOWARD EFFECTS AS A RESULT OF THE FAILURE TO CROSS. THE 2.25X15 MM XIENCE SIERRA WAS ADVANCED TO TREAT THE DISTAL LAD, BUT IT GOT CAUGHT ON THE HEAVY CALCIUM IN THE PROXIMAL LAD. WHEN THE STENT DELIVERY SYSTEM (SDS) WAS RETRACTED, THE STENT DISLODGED FROM THE SDS. A SMALLER DILATATION CATHETER WAS INSERTED THROUGH THE DISLODGED STENT, WHICH WAS DEPLOYED IN THE PROXIMAL LAD. ANOTHER XIENCE SIERRA WAS ABLE TO CROSS THE DISTAL LAD. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7952095 ↗
• InjuryAug 7, 2018Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A STIFF, HEAVILY TORTUOUS, HEAVILY CALCIFIED, 80% STENOSED LESION IN THE PROXIMAL TO DISTAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON DILATATION CATHETER (BDC). A 2.25 X 15 MM XIENCE SIERRA RX STENT DELIVERY SYSTEM (SDS) WAS THEN ADVANCED AND WAS UNABLE TO REACH THE DISTAL END OF THE LESION. DURING SDS REMOVAL FROM THE PATIENT ANATOMY, THE XIENCE SIERRA STENT GOT CAUGHT ON HEAVY CALCIUM AND DISLODGED IN THE PROXIMAL TO MID PORTION OF THE TARGET LESION. AN UNSPECIFIED BDC WAS THEN ADVANCED TO THE DISLODGED STENT, AND INFLATED TO DEPLOY THE STENT IN THE PROXIMAL TO MID PORTION OF THE TARGET LESION. FOLLOWING ADDITIONAL PRE-DILATATION, ATTEMPTS WERE MADE TO TREAT THE LESION WITH THREE DIFFERENT STENTS, BUT NOTHING WOULD CROSS, SO THE PROCEDURE WAS ABORTED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7759143 ↗
• InjuryJun 21, 2018Improper or Incorrect Procedure or Method; Physical Resistance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE CHRONIC TOTAL OCCLUSION IN THE RIGHT CORONARY ARTERY. TWO XIENCE SIERRA STENTS WERE SUCCESSFULLY IMPLANTED IN THE MID TO PROXIMAL RIGHT CORONARY ARTERY (RCA). THE 2.25 X 15 MM XIENCE SIERRA WAS ADVANCE INTO THE PATIENT ANATOMY, TO TREAT A DISEASED PORTION OF THE VESSEL THAT WAS DISTAL TO THE TWO IMPLANTED STENTS. RESISTANCE WAS NOTED ADVANCING THROUGH THE PREVIOUSLY IMPLANTED STENTS; HOWEVER, THE DEVICE WAS ABLE TO CROSS TO THE TARGET LESION. ONCE AT THE TARGET LESION, IT WAS NOTED THAT THE STENT WAS NOT ON THE DELIVERY SYSTEM. THE STENT WAS NOT SEEN IN THE PATIENT ANATOMY; HOWEVER, IT WAS FELT THAT THE STENT WAS ON THE DELIVERY SYSTEM WHEN IT WAS INSERTED INTO THE PATIENT ANATOMY. THE STENT COULD NOT BE LOCATED OUTSIDE THE PATIENT ANATOMY. A NEW XIENCE SIERRA STENT WAS THEN USED TO TREAT THE REMAINING LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7626036 ↗
• MalfunctionJun 15, 2018Difficult to Remove; Physical Property Issue

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE DISTAL POSTERIOR LATERAL CORONARY ARTERY THAT WAS MODERATELY TORTUOUS. THE XIENCE SIERRA 2.25 X 15 MM STENT WAS DEPLOYED AND THE BALLOON DEFLATED BUT THE STENT DELIVERY SYSTEM WAS UNABLE TO BE REMOVED FROM THE ANATOMY. THE BALLOON WAS RE-INFLATED A SECOND TIME AND WAS DEFLATED AND SUCCESSFULLY REMOVED FROM THE ANATOMY. IT WAS STATED THAT THE BALLOON WAS 'STICKY'. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7606752 ↗